On May 11, 2021 ASLAN Pharmaceuticals (Nasdaq:ASLN), a clinical-stage immunology focused biopharmaceutical company developing innovative treatments to transform the lives of patients, reported financial results for the first quarter ended March 31, 2021 and provided an update on its clinical development activities (Press release, ASLAN Pharmaceuticals, MAY 11, 2021, View Source [SID1234579692]).

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Dr Carl Firth, Chief Executive Officer, ASLAN Pharmaceuticals, said: "We have continued to make solid progress in 2021 and we are on track to complete the expansion cohort in our multiple ascending dose trial for ASLAN004 with an additional 27 patients expected to be enrolled by mid-2021 followed by the announcement of topline data expected in the third quarter of 2021. We are excited to expand our senior management team with two highly experienced executives, Dr Karen Veverka, who will be leading our clinical development program, and Joseph Suttner to lead clinical operations. In addition, we are preparing for our Phase 2b trial for ASLAN004, which we expect to initiate in the second half of 2021. Our robust financial position provides the resources to fund development activities and achieve additional value creating milestones for shareholders."

First quarter 2021 and recent business highlights

Clinical development

ASLAN004

Positive interim data from the three dose cohorts of the ongoing Phase 1 randomised, double-blind placebo controlled multiple ascending dose (MAD) study of ASLAN004 for the treatment of moderate to severe atopic dermatitis (AD) were announced in March. ASLAN004, a novel, first-in-class antibody, was well tolerated across all doses and showed improvements compared to placebo in all efficacy endpoints, supporting its potential as a differentiated treatment for AD. Additional data from the expansion cohort is planned for the third quarter of 2021.
New data from the Single Ascending Dose study that demonstrate ASLAN004’s favourable tolerability profile as an IL-13Rα1 inhibitor and as a differentiated treatment method for atopic dermatitis patients were accepted for poster presentation at the 2021 Society for Investigative Dermatology virtual meeting on 6 May. The data will also be published in the fall edition of the Journal of Investigative Dermatology.
Corporate updates

Appointed Dr Karen Veverka as Vice President, Medical to lead ASLAN’s clinical medical development program for new products, including Phase 2 and 3 trials. Dr Veverka brings more than 20 years of experience in the pharmaceutical industry, as well as significant preclinical and clinical research and development (R&D) experience in immunology and dermatology. Prior to joining ASLAN, Dr Veverka was Senior Medical Director and Medical Head for the Innovative Portfolio at LEO Pharma, a leader in global dermatology. At LEO she led the development of brand medical strategy and execution of medical affairs activities for products in the AD and psoriasis therapeutic areas, including tralokinumab. Dr Veverka has also held leadership roles at Novartis and GTx. Dr Veverka earned her PhD in Pharmacology at The Mayo Clinic Graduate School of Biomedical Sciences and completed a postdoctoral research fellowship at St Jude Children’s Research Hospital.
Appointed Joseph Suttner as Vice President, Clinical Operations. Mr Suttner brings more than 20 years in clinical operations and R&D, including more than 8 years in dermatology. Mr Suttner has successfully led clinical operations teams at Dermira, PellePharm and several other biotechnology companies through Phase 2b trials in AD, Gorlin syndrome, and actinic keratosis, among other conditions.
Anticipated upcoming milestones

Completion of MAD clinical study of ASLAN004 in moderate-to-severe AD patients with clinical results expected in third quarter of 2021.
Initiation of Phase 2b study of ASLAN004 for AD expected in the second half of 2021.
First quarter 2021 financial highlights

Cash used in operations for the first quarter of 2021 was US$7.6 million compared to US$5.2 million in the same period in 2020.
Research and development expenses were US$3.8 million in the first quarter of 2021 compared to US$2.4 million in the first quarter of 2020. The increase was driven by manufacturing expenses incurred in preparation for the Phase 2b trial of ASLAN004.
General and administrative expenses were US$3.1 million in the first quarter of 2021 compared to US$1.0 million in the first quarter of 2020. The increase was due to the increase in headcount and staffing costs in preparation for the Phase 2b trial of ASLAN004 and additional corporate costs incurred to support the fundraising activities that were concluded in the first quarter of 2021.
Net loss for the first quarter of 2021 was US$6.7 million compared to a net loss of US$3.0 million for the first quarter of 2020.
Cash, cash equivalents and short-term investments totalled US$100.8 million as of 31 March 2021 compared to US$14.3 million as of 31 December 2020. Following the financing activities in the first quarter of 2021, which raised combined gross proceeds of approximately US$101 million, management believes that its cash and cash equivalents will be sufficient to fund operations into 2023.
The weighted-average number of American Depository Shares (ADSs) outstanding in the computation of basic loss per share for the first quarter of 2021 was 51.4 million (representing 257.2 million ordinary shares) compared to 38.0 million (representing 190.0 million ordinary shares) for the first quarter of 2020. Following the financing activities in the first quarter of 2021, the number of ADSs outstanding on 31 March 2021 was 69.5 million (representing 347.6 million ordinary shares). One ADS is the equivalent of five ordinary shares.

On May 11, 2021 Ashvattha Therapeutics, a clinical stage biotech company focused on novel hydroxyl dendrimer therapeutics (HDTs) targeting unmet medical needs in neuro-oncology, neurology and ophthalmology, reported that it will present at the Sachs 7th Annual Immuno-Oncology Innovation Forum, held virtually, May 18-20, 2021 (Press release, Ashvattha Therapeutics, MAY 11, 2021, View Source [SID1234579708]).

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Jeffrey Cleland, Ph.D., Chairman, CEO and President of Ashvattha Therapeutics will provide an overview of the company, and its pipeline enabled by a proprietary hydroxyl dendrimer (HD) technology platform – a differentiated, superior approach to targeted intracellular therapy.

"We are excited to present our strategy in neuro-oncology therapeutics for the first time at the Sachs Immuno-Oncology Forum," said Jeffrey Cleland, Ph.D., Chairman, CEO & President at Ashvattha Therapeutics. "There remains a significant unmet need in treating primary and metastatic brain cancers with therapeutic agents that can cross the blood brain barrier and precisely target tumor associated macrophages. We are developing an HD imaging agent, D6-B483, to demonstrate uptake of HDs in gliomas and brain metastases. This agent will also be used as a radiotherapeutic. HDTs currently in preclinical studies are designed to manipulate the tumor microenvironment toward a pro-inflammatory state increasing innate immune responses to the tumor."

Ashvattha’s technology platform consists of HDs that selectively target regions of inflammation within the body. Current cancer treatments have dose-limiting toxicity reducing efficacy, and even precision medicine and targeted therapies lack sufficient specificity to tumors. Most cancer drugs do not cross the blood-brain barrier (BBB) to treat brain cancer. In addition, current immune therapies do not target tumor-associated macrophages (TAMs). Ashvattha’s HDTs widen the therapeutic window and increase the maximum tolerated dose, for better patient outcomes. Its proprietary compounds also target and treat brain tumors with durable effects inside TAMs for up to 30 days. Ashvattha is currently on track to initiate a D6-B483 Phase 1 study in patients with glioblastoma multiforme or brain metastases by end of 2021.

The 7th Annual Immuno-Oncology Innovation Forum is designed to bring together thought leaders from cancer research institutes, patient advocacy groups, pharma and biotech to facilitate partnering, funding and investment. Members of the management team will be available for virtual meetings at the conference. For more information, visit the conference website: View Source

On May 11, 2021 Imvax, a clinical stage immuno-oncology company driven to transform patient treatment and outcomes with its novel technology platform, reported that John Furey, chief executive officer, will present at the UBS Global Healthcare Virtual Conference at 1 p.m. EDT Wednesday, May 26, 2021 (Press release, Imvax, MAY 11, 2021, View Source [SID1234579725]).

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Mr. Furey, Dr. David Andrews, chief medical officer, and Dr. Mark Exley, chief scientific officer, will also participate in one-on-one investor meetings during the conference.

The presentation will be webcast live and will be available for replay for 30 days following the event at https://bit.ly/3gPPF8U.

On May 11, 2021 Eli Lilly and Company (NYSE: LLY) and MiNA Therapeutics Limited, a pioneer in RNA activation therapeutics, reported a global research collaboration to develop novel drug candidates using MiNA’s proprietary small activating RNA (saRNA) technology platform (Press release, Eli Lilly, MAY 11, 2021, View Source [SID1234579662]).

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Under the terms of the agreement, MiNA will utilize its saRNA platform to research up to five targets selected by Lilly that aim to address diseases across Lilly’s key therapeutic focus areas. Lilly will be responsible for preclinical and clinical development of candidates and will retain exclusive commercialization rights for any products resulting from the collaboration. MiNA will receive a $25 million upfront payment and is eligible to receive potential development and commercialization milestones up to a total of $245 million per target, as well as tiered royalties from the low-single to low-double digits on product sales resulting from the collaboration.

"Small activating RNAs are a promising new technology, which will expand the breadth of Lilly’s RNA therapeutics platform and the targets we can pursue," said Andrew C. Adams, Ph.D., vice president for new therapeutic modalities at Lilly. "We are excited about the potential of combining MiNA’s leading saRNA platform and our expertise in new modalities to accelerate development of RNA-based medicines in areas of high unmet medical need."

"This collaboration with Lilly is an important validation of our saRNA platform," said Robert Habib, CEO of MiNA Therapeutics. "Lilly’s expertise in the field of RNA therapeutics and clinical development will greatly enhance our efforts to realize the technology’s full potential. Together, we aim to unlock new targets in multiple therapeutic areas and to ultimately move them towards clinical development and commercialization."

This transaction will be reflected in Lilly’s reported results and financial guidance according to Generally Accepted Accounting Principles (GAAP). There will be no change to Lilly’s 2021 non-GAAP earnings per share guidance as a result of this transaction.

On May 11, 2021 Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX), a specialty pharmaceutical company, reported that provided a company update and first quarter 2021 financial results (Press release, Cumberland Pharmaceuticals, MAY 11, 2021, View Source [SID1234579677]). Net revenues from continuing operations during the quarter were $10.5 million, a 26.5% increase over the prior year period. The company also recorded an additional $500,000 in revenue during the first quarter associated with divested product rights for two brands it is no longer distributing.

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The Company’s financial position included $93 million in total assets – with $25 million in cash, $46 million of total liabilities, and $47 million of shareholders’ equity at the end of the quarter.

"As the novel coronavirus continues to affect lives over a year after its arrival in the U.S., we remain hopeful, as an overall reopening of our country is now in progress," said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals. "Given all the challenges of operating a business in the wake of a pandemic, Cumberland was able to generate solid financial performance by adjusting our market strategies, retooling our sales communications and reinventing the way in which we operate our business."

RECENT COMPANY DEVELOPMENTS:

Vibativ Case Studies

Cumberland’s Vibativ product has been used across the country to help COVID-19 patients who develop secondary bacterial infections in their lungs. Vibativ is a patented, FDA-approved injectable anti-infective for the treatment of certain serious bacterial infections including hospital-acquired and ventilator-associated bacterial pneumonia that can result from COVID-19, flu, and other infections.

The Company subsequently compiled a dossier of patient case studies from across the country outlining several real-world instances where Vibativ effectively and safely treated the hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia resulting from MSSA and MRSA infections that developed in patients hospitalized with COVID-19.

RediTrex Launch

The Company is now finalizing plans for the full launch of its FDA-approved RediTrex product line. RediTrex is approved for patients with severe, active rheumatoid arthritis and polyarticular juvenile idiopathic arthritis who have difficulty tolerating or responding to orally delivered methotrexate. It is also approved for symptomatic control of severe, recalcitrant, disabling psoriasis in adults who are not adequately responsive to other forms of therapy.

Cumberland initially implemented a soft launch during the fourth quarter of 2020 and is currently planning a national launch of the product line during the second half of 2021, once additional product supplies are received and market conditions return to normal.

Hyponatremia Publication in Support of Vaprisol

A recent study publication called Health Outcome Predictive Evaluation (HOPE) COVID-19 Registry Analysis, an international study of over 4,000 patients, found that patients hospitalized with COVID-19 had a high risk of developing hyponatremia. These COVID-19 patients also had a higher incidence of mortality due to their hyponatremia. The study results support the use of an intravenous vaptan to treat hyponatremia in critically ill patients afflicted with COVID-19.

Hyponatremia, an imbalance of serum sodium to body water, is the most common electrolyte disorder among hospitalized patients. Cumberland’s Vaprisol product is one of two branded prescription products indicated for the treatment of hyponatremia, and the only intravenously administered branded treatment. Vaprisol has a proven day-1 response to help normalize serum sodium levels in hyponatremic patients and move them out of the ICU as efficiently as possible.

FINANCIAL RESULTS:

Net Revenues: For the three months ended March 31, 2021, net revenues from ongoing operations were $10.5 million, up 26.5% from $8.3 million for the prior year period. The company also recorded an additional $500,000 in revenue during the first quarter associated with divested product rights.

Net revenue by product for the three months ended March 31, 2021, included $5.1 million for Vibativ, $3.0 million for Kristalose, $1.5 million for Caldolor, and $1.1 million for Vaprisol.

Operating Expenses: Total operating expenses for the three months ended March 31, 2021, were $10.9 million, compared to $10.2 million during the prior year period. This increase in expenses resulted primarily from the additional cost of goods associated with our growth in Vibativ sales during the quarter.

Earnings: Net income for the first quarter 2021 was $0.2 million or $0.01 a share, compared to a loss of $1.1 million or $0.07 a share for the prior year period.

Adjusted Earnings for the first quarter were $1.1 million or $0.07 per diluted share, compared to a loss of $0.4 million or $0.03 per diluted share for the prior year period.

Balance Sheet: At March 31, 2021, Cumberland had $93.3 million in total assets including $24.9 million in cash and cash equivalents. Total liabilities were $46.5 million, including $15.0 million outstanding on the Company’s revolving line of credit, resulting in total shareholders’ equity of $47.0 million.

Conference Call and Webcast

A conference call and live internet webcast will be held on Tuesday, May 11, at 4:30 p.m. Eastern Time to discuss the results. To participate in the call, please dial 877-303-1298 (for U.S. callers) or 253-237-1032 (for international callers). A rebroadcast of the teleconference will be available for one week and can be accessed by dialing 855-859-2056 (for U.S. callers) or 404-537-3406 (for international callers). The Conference ID for the rebroadcast is 7973325. The live webcast and rebroadcast can be accessed via Cumberland’s website at View Source